Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement

Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement

Efficacy and Safety of Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial

The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.

The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.

Inclusion Criteria: Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied. 2. On the Screening date, Stroke onset date is not over 60 days. 3. ESUS Diagnosis : all of a~e must be satisfied. a. Ischemic stroke detected by CT or MRI that is not lacunar b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on) e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse) 4. cardioembolism is classified by TOAST classification. 5. Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2 6. Voluntarily sign the consent form Exclusion Criteria: Transient cerebral ischemic attack Active cancer Heart embolism, stroke of major heart embolism, stroke high-risk disease Left atrial thrombus Left ventricular thrombus Sick sinus syndrome Myocardiac infarction in 1 month Rheumatic left atrioventricular valve or aortic valve disease Artificial heart valve Myocardiac infarction (EF<28%) Congestive heart failure (EF<30%) Dilated cardiomyopathy Nonbacterial thrombotic endocarditis Endocarditis Intracardiac mass Atrial fibrillation Restriction for echocardiography (obesity, lung disease etc) High risk PFO Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis) Implant cardiac pacemaker Life-threatening arrhythmia Radiation therapy or MRI scan Restriction for Cardia SOLO attachment The person who investigator judged unsuitable for the trial